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# Clinical Hold Lifted on Neurizon ALS Drug
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-neurizon-als-drug/
- Published: 2025-10-06T12:00:00.000Z
- Updated: 2026-09-14T15:23:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159988

FDA has lifted a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis (ALS), clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, which is expected to begin later this quarter.

“Supported by our compelling TDP-43 preclinical data and encouraging survival outcomes from the open-label extension study in ALS patients, we believe NUZ-001 has the potential to meaningfully slow the progression of this devastating disease,” the company says.

NUZ-001 showed efficacy in reducing protein aggregation and preserving neuronal function in preclinical studies, Neurizon says. The therapy is said to inhibit mTOR signaling, which is involved in cell growth and the regulation of autophagy, a cellular process that breaks down unneeded or damaged cellular components.